Data / Medical devices / India / Indius Medical Technologies Pvt. Ltd.
Indius Medical Technologies Pvt. Ltd.: FDA-registered device maker in Pune Maharashtra, India, 2 510(k) clearances
Indius Medical Technologies Pvt. Ltd. is registered with the FDA (registration 3014938863) in Pune Maharashtra, India. It lists 30 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 26, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014938863
- Address
- Unit No.12 Electronic Co-operative Estate, Pune - Satara Road, Pune Maharashtra, India, 411009
- Owner or operator
- Indius Medical Technologies Pvt. Ltd. (10058793)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 30, 2018
- Registered through
- 2026
- Brand names listed
- 4 mm Tapered Tap, 4 mm tap (Straight), 4.5 mm Tapered Tap, 4.5 mm tap (Straight), 5.5 mm Tapered Tap, 5.5 mm tap (Straight), 6.5 mm Tapered Tap, 6.5 mm tap (Straight) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Curette | HTF | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Fork | HXE | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Contract manufacturer | accessdata.fda.gov |
| Mallet | HXL | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Positioner, Socket | KIL | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pusher, Socket | HXO | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Contract manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Contract manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 26, 2020 | K200937 | ACURA Stabilization System | NKB | Substantially Equivalent | Indius Medical Technologies Pvt. , Ltd. | accessdata.fda.gov |
| March 24, 2020 | K200224 | SEA-LINK Anterior Cervical Plate System | KWQ | Substantially Equivalent | Indius Medical Technologies Pvt. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Awl
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Instrument, Compression
- All makers of Wrench
Updated October 26, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.